Cleared Traditional

K780660 - NITE TRAIN'R

K780660 is the FDA 510(k) clearance for NITE TRAIN'R by Nite Train-R Enterprises, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KPN) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K780660 · Nite Train-R Enterprises, Inc. · Gastroenterology & Urology device
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Jul 1978
Decision
99d
Days
Class 2
Risk

K780660 is an FDA 510(k) clearance for the NITE TRAIN'R. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Nite Train-R Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1978 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.2040 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nite Train-R Enterprises, Inc. devices

Submission Details

510(k) Number K780660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1978
Decision Date July 28, 1978
Days to Decision 99 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPN Alarm, Conditioned Response Enuresis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.